In Reply: In response to Dr Bierma-Zeinstra
and colleagues, patient compliance was defined as the percent of tablets taken
(according to patient report) relative to the number prescribed, an accepted
and common method of compliance measurement in clinical trials.1
Percent compliance for each patient was calculated as the mean percent compliance
of the 4 bottles of blinded study medication, irrespective of treatment group
to which the patient was assigned. Since more than the number of tablets needed
to complete the study were included in each bottle (to ensure sufficient drug
in case of accidental losses), if a patient took more tablets than prescribed,
the percent compliance would be greater than 100% (this was uncommon). Descriptive
statistics for percent compliance for patients randomized to treatment who
provided efficacy data are shown in the Table 1.